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Screening – Week 12; 1 - 78 (MOD1)
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BDI (Baseline & Week 12), Epworth Sleepiness Scale (Baseline & Week 12); 301 - 312 (MOD2)
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Week 14 – Week 20; 79 - 102 (MOD3)
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BDI ( Week 20), Epworth Sleepiness Scale (Week 20); 313 - 318 (MOD4)
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Week 22 – Week 28; 103 - 120 (MOD5)
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BDI (Week 28), Epworth Sleepiness Scale (Week 28); 319 - 324 (MOD6)
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Week 30 – Week 36; 121 - 145 (MOD7)
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BDI (Week 36), Epworth Sleepiness Scale (Week 36); 325 - 330 (MOD8)
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Early Withdrawal, Follow-up (Week 38), Unscheduled dose changes (1-6), Concomitant medications, AEs, SAEs, Study Conclusion; 146 - 178 (MOD9)
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BDI (Early Withdrawal). Epworth Sleepiness Scale (Early Withdrawal); 331 - 336 (MOD10)